Conventional nasogastric tubes have been in use for many years. Complications include trauma related to tube insertion and effects from use of the tube for prolonged periods of time. Occasionally, severe complications such as tracheo-esophageal fistula and perforation of various organs have been reported. Gastrointestinal bleeding of various magnitudes also can occur but less frequently. In addition, feeding tubes inserted through the nose or mouth are acceptable for short period, but such tubes must be replaced by other means for extended delivery of nutrition.
As described in U.S. Pat. No. 6,554,700, patients for which normal ingestion of food becomes difficult or impossible, may require placement of a feeding tube to assist in providing their nutritional needs. For some individuals, such as comatose patients, stroke victims, or those with a compromised gastrointestinal tract, this may require placement of a tube that is introduced percutaneously into the stomach for delivery of nutritional products and medication.
In percutaneous endoscopic gastrostomy (PEG), the procedure involves introduction of a gastroscope into the stomach, while the desired site where a stoma is to be created, occurs by depressing the abdomen. A sheathed needle punctures the abdominal wall and enters the stomach, creating a stoma. The needle is removed and a looped insertion wire is introduced through the sheath where it is grasped by a snare deployed from a working channel of the gastroscope. Once it is captured, the insertion wire is pulled into the channel of the gastroscope. The gastroscope is then withdrawn from the patient via the oral cavity, pulling the wire with it.
In the standard Ponsky method (or “pull” method), the distal loop of a percutaneous gastrostomy feeding tube is coupled to the insertion wire loop exiting the patient's mouth. With the insertion wire now tethered to the gastrostomy feeding tube, the endoscopist then retracts the insertion wire exiting the stoma, thereby pulling the gastrostomy feeding tube into the patient's mouth and on toward the stomach. The tapered dilator portion aids in allowing the gastrostomy feeding tube to pass through the stoma. Once the tube has been properly positioned with the end cap snug against the internal wall of the stomach, the dilator portion of the gastrostomy feeding tube is cut away. Finally, the internal position of the gastrostomy feeding tube is checked by reintroducing the gastroscope.
As described in U.S. Pat. No. 5,073,166, the pull procedure has several disadvantages, one of which is the fact that, for both emplacement and removal, an endoscope must be inserted into the patient's esophagus, requiring anesthesia and causing discomfort to the patient. Also, the catheter itself must pass through the patient's esophagus, once for emplacement and once for removal. This becomes even more problematic when secondary or replacement catheters are put in place, since each time the catheter is changed, the “pull” procedure must again be followed, with increased likelihood of trauma, infections, and other complications.
Furthermore, the pull procedure is particularly difficult to carry out when a patient has an obstruction in the esophagus, which is a problem compounded by the fact that it is just such people who are likely to need the procedure. When there is an obstructive lesion in the esophagus, one may need to dilate the narrowed area to perform the procedure. This may expose the patient to a higher risk of bleeding or perforation as the tethered tube is pulled blindly during the procedure. Another disadvantage arises from the fact that infectious or cancerous matter may be drawn from a diseased area in, for example, the throat, down into the stomach, with the possibility of spreading the disease further, especially to the area around the freshly formed opening in the stomach.
In the variation of a percutaneous endoscopic gastrostomy procedure known as the “push” method or the Russell procedure, the gastrostomy feeding tube is a pull wire, but is pushed down the esophagus by the physician and into positioned in the stomach. As with the “pull” method, the gastroscope is usually reintroduced to verify that the end cap is properly positioned against the stomach wall. In the Russell procedure, a needle is first inserted into the stomach (at a site located by endoscopy, as with the pull procedure), and then a guide wire is inserted through a lumen in the needle. A small incision is then made in the fascia next to the guide wire, after which an interiorly lubricated sheath having a splittable seam is guided, along with a tapered dilator, over the guide wire and into the stomach. Once the sheath is in place, the dilator and guide wire are removed, and a balloon catheter is inserted through the lubricated central lumen of the sheath. A distal balloon of the catheter is then inflated, and the sheath is peeled or split away along its seam or seams, thus leaving the catheter emplaced in the stomach. Sutures are provided to maintain tension of the balloon against the peritoneum. However, the splittable sheath is necessarily larger in diameter than the catheter which is inserted through it for emplacement within the stomach. Therefore, the opening into the stomach is made overly large, making sealing difficult and increasing the likelihood of infection. The sheath may not be made too narrow, or the physician will not be able to insert the catheter through it, and thus there is a trade-off between insertability of the catheter and the quality of the seal once the catheter is in place; the dilator must closely follow the line of the guidewire, so as not to buckle the wire into the peritoneal cavity. Occasionally, during placement of the feeding tube, the dilator is removed and the peelable sheath is left behind in the stomach, allowing air in the distended stomach to escape, causing the stomach to collapse. Then a patient must be taken to the operation theater for an open placement feeding tube insertion.
A procedure known as Sacks-Vine involves passing an endoscope down the throat until its terminus is in the interior of the stomach. A Seldinger needle is then externally inserted through the various tissue layers until it enters the stomach at a predetermined point. The needle is retracted leaving only the Seldinger cannula in place and a guidewire is then inserted through the stoma. The terminal end of the guidewire is grabbed by the endoscope and retracted up the throat. A tapered dilating catheter attached to the gastrostomy port is passed over the guidewire then inserted down the throat, through the esophagus and into the stomach so as to form, upon removal of the catheter through the abdominal skin, an opening wide enough to accommodate a trailing gastric port. At the proximal end of the gastrostomy port is a retention device that keeps the proximal end of the catheter from passing through the gastrocutaneous stoma. A feeding set adapter is then hooked up to the portion of the catheter external of the body that allows the gastrostomy port to be used for the actual feeding of the patient. Like the pull method, the Sacks-Vine procedure requires another endoscopic procedure for removal of the tube upon cessation of enteral feeding or upon the necessity of changing the tube. This additional procedure results in additional trauma associated with any endoscopic procedure, as well as cost, to the patient. In addition, if blind placement of the G tube (i.e., without endoscopic visualization) occurs, re-endoscopy is necessary to exclude trauma in the path of the Q-tube. The procedure may cause trauma and bleeding as the G tube is pushed or pulled. Also, the insertion of the G-tube can be more traumatic if the esophagus has been dilated due to esophageal stricture. If there is a malignant stricture present, there is a risk that the peritoneal space may be seeded with cancerous matter. This procedure is subject to infections from the inside out displacement of the feeding tube.
In yet another technique of feeding described in U.S. Pat. No. 6,322,495, an introducer technique is used. The introducer technique differs from the push and pull techniques in that the feeding tube is inserted through the abdominal wall and not through the mouth. After an endoscope is advanced into the stomach, a T-fastener is placed to move the stomach close to the abdominal wall. A needle is inserted through the abdominal wall into the stomach to create an opening. A guide wire is advanced through the opening, and an introducer with a peel-away sheath is passed over the guide wire. The introducer is then removed, and a gastrostomy tube is inserted into the stomach through the peel-away sheath. The feeding tube is a catheter with a Foley balloon at its distal end. The balloon is inflated to retain the feeding tube inside the stomach. The sheath is then peeled away, leaving behind the feeding tube. In addition, this feeding technique is cumbersome to utilize and requires multiple steps in addition to the step of direct insertion of a T fastener. Also, the number of punctures, are increased, resulting in higher probabilities of infections and failures. As the introducer is peeled off, there is a risk of air leaking.
Many attempts have been made to make percutaneous gastrostomy simpler. Iwatschenko, in U.S. Pat. No. 4,834,725, describes a catheter for introduction through the abdominal wall into the gastric lumen where it is secured against slipping out of the stomach of its end by a portion of a catheter assuming a spiral configuration in the interior of the stomach and resting on the stomach wall upon withdrawal of a trocar. With this method, the inner portion of the catheter can be easily pulled out by the patient because any upward pulling would uncoil the inner part of the G tube. This method also runs the risk of trauma to the stomach wall and increased G tube clogging, due to the long, spiral shape of the intra-gastric part of the tube.
As described in U.S. Patent Publication No. 2007/0016172, a tapered dilator feeding tube portion aids in allowing the gastrostomy feeding tube to pass through the stoma and once the tube has been properly positioned with the end cap snug against an internal wall of the stomach, after the dilator portion of the feeding tube is cut away, a rubber bumper, also known as an external retention member, is prepared and positioned on the feeding tube as it emerges from the abdominal wall, and once the feeding tube is secured in place, a Y-port adapter is connected to it. These additional steps add complexity. Furthermore, the dilator needs to be cut away in this method. This procedure runs the risk of requiring re-scoping the stomach to confirm successful placement and enhances the risk of infection and carrying malignant cells from the mouth and esophagus to the peritoneal space, as with other inside out procedure.
Ross in U.S. Pat. No. 6,015,400, describes a method for placing a feeding tube unit, which involves placement of a dilating device having a proximal end portion and a distal end portion and positioning a feeding tube unit defining a channel such that a distal end portion of the feeding tube is positioned within the channel defined through the dilating device and the feeding tube is urged into a gastrointestinal tract of a patient followed by removal of the dilating device. However, there is a possibility of leaks occurring through this method.
Also, Gastrostomy tube percutaneous insertion kits are known, such as the Kimberly-Clark™ Introducer Kits, a class II medical device. Such kits include a gastropexy, a dialtor with a peel-away sheath, a syringe, a hemostat, an introducer needle, a seeking catheter, a scapel, a guidewire and a stoma measuring device, for example. In one example, a kit is intended to facilitate the primary placement of a gastrostomy feeding tube. In another example, a different kit is intended to facilitate primary placement of a transgastric jejunal feeding tube using endoscopic/radiologic placement. A transgastric jejunal feeding tube is known that uses a balloon on a stylet with a diameter of 22 centimeters and a length of 45 centimeters and a volume of 7-10 milliliters, which is used for pulling or pushing the transgastric jejunal feeding tube to a jejunal location. Both the gastrostomy tube and the jejunal tube may be fixed in place using a bolster.
In one known example, a combination of transgastric jejunal feeding tube and a gastrostomy feeding tube is provided. The jejunal feeding tube may be inserted through the lumen of the gastrostomy feeding tube. A Y-port connector end of the jejunal feeding tube may be pressed into the lumen of the gastrostomy tube to complete placement and to allow for gastric drainage through the gastrostomy tube. A combined gastrostomy tube and jejunal feeding tube is an improvement over separate gastrostomy tubes and jejunal tubes, which require removal of the gastrostomy tube prior to inserting a jejunal tube, but the combined gastrostomy tube has complications and requires a multi-part Y-port connector end to be positioned and retained in the lumen of the gastrostomy tube. A Bard™ Tri-Funnel Replacement Gastrostomy Tube has a concentric balloon collar a the end inserted into the stomach that minimizes the potential for accidental removal of the clear silicone feeding tube and an adjustable bolster is used externally opposite of the concentric balloon to fix the gastrostomy tube in the patient's stomach. It is a simple device that provides a balloon collar at one end of the gastrostomy feeding tube and is designed to be a replacement tube.
All materials of such devices that come into direct contact with the patient have a history of use in medical devices and are biocompatible, sterile and functionally safe and effective for use in humans. However, insertion and removal may cause infection and complications, nonetheless, due to contamination during insertion, positioning or use of prior art gastrostomy tubes, jejunal tubes or combination gastro-jejunal tubes.